冷沉淀凝血因子制备工艺的改良

目的建立一种冷沉淀凝血因子的制备方法,确保产品质量符合预期要求。方法取筛选预留的保存期内的新鲜冰冻血浆,采用循环水浴,并将初始温度控制在15℃,定期观察水温,保证在30 min内水温达到4℃,然后维持4℃水温30 min,在4℃无菌条件下分离出沉淀在血浆中的冷不溶解物质并在1 h内冻结。以纤维蛋白原和Ⅷ因子含量为质控项目。结果改良的方法通过调整融化时的初始水温、采用循环水浴确保水温均匀度,与原工艺比较,缩短融化时间2 h。36袋制品的纤维蛋白原和Ⅷ因子含量均符合国家要求并好于原方法,临床使用效果良好。结论此方法优于原传统方法,可推广应用。     

冷沉淀凝血因子制备工艺的改进

建立一种冷深沉凝血因子的制备方法,确保产品质量符合预期要求。取筛选预备的保存期内的新鲜冰冻血浆,循环水浴,并将初始温度控制在15℃,定期观察水温,在30 min内水温达到4℃,然后维持4℃水温30 min,在4℃无菌条件下分离出沉淀在血浆中的冷不溶解物质并在1 h内冻结。以纤维蛋白原和Ⅷ因子含量为质控项目。结果36袋制品的纤维蛋白原和Ⅷ因子含量均符合国家要求并好于原方法,临床使用效果良好。此方法优于原传统方法,可推广应用。     

虹吸法制备冷沉淀的关键控制点

目的研究虹吸法制备冷沉淀的关键控制点,旨在为临床提供高质量的冷沉淀。方法选取30袋新鲜备用血浆随机分为三组即A组、B组、C组,每组各10袋,A组水温恒定在2℃,B组水温恒定在4℃,C组水温恒定在6℃。利用血凝仪检测冷沉淀中第Ⅷ因子和纤维蛋白原的含量。结果三组不同水温制备的冷沉淀第Ⅷ因子和纤维蛋白原的含量均符合GB18469-2001《全血及成分血质量要求》,但冷沉淀中第Ⅷ因子的含量,A组与B、C两组比较有显著性差异(P<0.05),而B、C两组之间比较无显著性差异(P>0.05),纤维蛋白原的含量三组之间比较无显著性差异(P>0.05),A、B、C三组平均用时分别为160min,65min,50min。结论为了提高产品质量和工作效率,虹吸法制备冷沉淀的水浴温度应恒定在4～6℃之间较好。     

不同型号血凝仪检测冷沉淀中Ⅷ因子和纤维蛋白原结果比较

<正>冷沉淀的检测指标主要是凝血因子Ⅷ和纤维蛋白原(Fbg),临床上主要用于甲型血友病、血管性假性血友病以及先天性或获得性纤维蛋白缺乏导致的出血、外科大手术及大出血的治疗,冷沉淀凝血因子质量的差异直接影响治疗效果。CA-50和CA-510是希森美康公司CA系列的半自动/全自动血凝仪,依据散色光加百分比(去本底)原理,可快速对血液中的凝血因子进行相关检测。为了更好地对冷沉淀     

单采新鲜冰冻血浆在制备冷沉淀凝血因子中的应用

目的 探讨单采新鲜冰冻血浆在制备冷沉淀凝血因子中的应用效果.方法 选取2020年4～10月肇庆市中心血站采集的48袋血浆,采用随机数字表法分为实验组(24袋)与对照组(24袋).实验组采用单采新鲜冰冻血浆制备冷沉淀凝血因子、对照组采用全血制备的新鲜冰冻血浆制备冷沉淀凝血因子,比较两组冷沉淀凝血因子中的Ⅷ因子(FⅧ)含量...     

人凝血因子Ⅷ生产冷沉淀制备工艺的优化

目的：通过优化冷沉淀制备过程中的工艺条件,获得最佳的人凝血因子Ⅷ生产用冷沉淀的制备工艺。方法主要对溶解过程中的夹层循环水温度、搅拌转速和离心过程中的离心机转速、出液温度和进液速度等影响因素进行考察,以人凝血因子Ⅷ效价为衡量指标进行研究。结果通过该试验研究,获得的最佳制备工艺为：循环水温度大于25～30℃,搅拌转速100 r/min,离心机转速14000 r/min,出液温度0～2℃,每台进液速度为3 kg/min。结论通过该试验研究,获得了最佳的人凝血因子Ⅷ生产用冷沉淀的制备工艺,为提高人凝血因子Ⅷ的质量和产量奠定了基础。     

4种冷沉淀凝血因子制备方法的比较研究

目的 探讨4种制备方法对冷沉淀凝血因子质量的影响。方法 将160袋新鲜冰冻血浆随机分成4组,每组40袋,分别用4种不同制备方法[Pool方法(A组)、虹吸法(B组)、水浴离心法(C组)及基于虹吸法改良的全自动冷沉淀制备仪法(D组)]制备冷沉淀凝血因子。比较4组凝血因子Ⅷ(FⅧ)、纤维蛋白原(FIB)水平及其回收率。结果 4组FⅧ和FIB水平比较,差异有统计学意义(P<0.05)。A组FⅧ水平与D组比较,差异有统计学意义(P<0.05);B组FⅧ水平分别与C组、D组比较,差异有统计学意义(P<0.05)。B组FIB水平分别与A组、C组、D组比较,差异有统计学意义(P<0.05)。4组FⅧ回收率比较,差异有统计学意义(P<0.05)。4组FIB回收率比较,差异无统计学意义(P>0.05)。A组FⅧ回收率与D组比较,差异有统计学意义(P<0.05);B组FⅧ回收率分别与C组、D组比较,差异有统计学意义(P<0.05)。结论 采用基于虹吸法改良的全自动冷沉淀制备仪制备冷沉淀凝血因子的方法最优,其可有效控制制备操作过程中影响质量的诸多因素,有效降低...     

新鲜冰冻血浆与普通冰冻血浆制备冷沉淀的质量分析

目的通过对新鲜冰冻血浆、普通冰冻血浆制备冷沉淀Ⅷ因子质量测定,来确定普通冰冻血浆是否合适做冷沉淀原料浆。方法随机抽取2009-2010年新鲜冰冻血浆、普通冰冻血浆各10份,制备冷沉淀后,利用凝血法,检测其中Ⅷ因子含量并计算FⅧ合格率。结果新鲜冰冻血浆FⅧ含量为（0．94±0．13）IU／mL,普通冰冻血浆FⅧ含量为（0．42±0．16）IU／mL,两组差异有统计学意义。结论冷沉淀制备需要用新鲜冰冻血浆。     

因子分析法在门诊药房工作质量综合评价中的实践

目的通过因子分析的方法建立门诊工作质量综合评价指标体系。方法记录2013年全年门诊药房的相关研究指标,通过因子分析法对指标进行分析,并找到影响门诊药房工作质量的潜在影响因子,讨论各个因子及控制意义。结果经过因子分析,抽取与门诊药房工作质量密切相关的3个公因子作为研究对象,按影响大小依次为"处方调配因子"、"药学服务因子"和"药品不良反应发生因子"。数据表明,处方调配仍然是门诊工作质量的重点,要在抓好处方调配的基础上逐项进行药学服务的开展,不断提高门诊药房工作质量。结论通过因子分析,能够建立一套有效的门诊药房工作质量综合评价体系,持续改进工作质量。     

An improved method for analysis of urinary hydroxyproline by an automated analyzer

An improved method of analysis has been devised for estimating the amount of hydroxyproline excreted into the urine. This study has been performed to overcome the difficulties accompaning mass-examinations which are indispensable in epidimiological studies. Urine samples are pretreated with a resin-charcoal mixture for elimination of interfering substances or color inhibitions, and the supernatant is treated by evaporation to avoid complications followed by pH adjustment. The residue is reconstituted with diluted HCL. After pretreatment, samples a analyzed with an automated analyzer. Linearity of standard calibration curve, and recovery and reproducibility of this assay are satisfactory. This simple procedure of analysis requires little time. This method is also useful for routine clinical examinations.     

因素重构分析法在硫霉素发酵中的应用

应用因素重构分析法来改良硫霉素产生菌卡特利链霉菌PRu-336(Streptomyces cattltya PRu-336)发酵培养基，将初步积累的实验数据输入一般化重构分析程序(Genrecx)，根据计算的结果，设计了F5A和F5B培养基，F5A效价比对照培养基F5提高52．6％，F5B效价比对照培养基F5提高36．8％。     

人凝血因子制品稳定剂赖氨酸含量测定方法的建立

目的   建立一种检测人凝血因子制品中游离氨基酸含量的方法。方法 采用茚三酮显色法结合三氯醋酸去蛋白质方法,利用分光光度计建立标准曲线,定量测定制品中的赖氨酸含量。结果   用该方法绘制的标准曲线具有很好的相关性,相关系数(r)为0.9994±0.0004,线性范围为5.2～26.0 mg／L,试验内和试验间的变异系数分别为1.07％和3.06％,回收率为94.60％～97.60％。与氨基酸分析仪测定法比较,结果相近。结论   本方法简便快速,灵敏度和准确度高,重复性好,适用于人凝血因子制品的生产质控。     

心包积液73例病因分析

目的了解导致心包积液的病因及其年龄构成,以提高临床诊疗水平,降低误诊率。方法对73例心包积液患者按照年龄分为青少年组、中年组与老年组,分别分析其致病因素与病因的年龄构成特点。结果肿瘤、心力衰竭、结核、非特异性心包炎、非结核性细菌感染是主要致病因素,另外肾功能不全、外伤、心肌炎、急性心肌梗死、胶原组织病、甲状腺功能减退也是致病因素。三组患者致病因素构成的比较差异有统计学意义（P〈0．01）。结论心包积液的致病因素受多种因素的影响,且年龄构成差异大。     

Quality control programme for the preparation of small-pool lyophilized heat-treated cryoprecipitates

International and national documents on and standards for quality control have been introduced for Blood Banks. Recently, the Standard Registration Document and a National Health Authority Licence for factor VIII preparations based on that Document were introduced in the Netherlands. In the course of developing a preparation of lyophilized heat-treated cryoprecipitates in our Blood Bank, we used this Standard Registration Document and the good pharmaceutical manufacturing practices to design a quality control protocol. The aim of this protocol was to provide documented evidence on the quality of both our product and the production process. The protocol included the validation or revalidation of individual installations and procedures used during production, validation of the whole process and quality control of routine production. With our quality protocol we have been able to demonstrate that our preparation is consistently of the intended quality.     

Bioanalytical method by HPLC-FLD for curcumin analysis in supplemented athletes

In sports, curcumin, a substance derived from the rhizome of Curcuma longa (turmeric) plant with antioxidant effect 8 times greater than vitamin E, has attracted the attention of scientists because of its potent antioxidant action, since in athletes subjected to intense exercise the—endogenous mechanisms of neutralization of reactive species are saturated. However, the pharmacokinetic characteristics of curcumin do not favor its medicinal use due to its low absorption, accelerated metabolism and rapid systemic elimination. Thus, the determination of plasma levels in supplemented patients is a crucial step in their pharmacodynamic evaluation. Therefore, the objective of this work was to develop and validate an analytical method by HPLC-FLD for curcumin evaluation in plasma of supplemented athletes. Luna column (C18; 150 × 4 mm; 3 µm), acetonitrile: acetic acid pH 3.2 (45:55 to 60:40) as mobile phase, flow rate of 1 mL min⁻¹, excitation at 429/285 nm and emission at 529 nm and injection of 10 µL were the chromatographic conditions used. Plasma samples were extracted using ethylacetate and methanol (95: 5, 500 µL) and estradiol (30 µg mL⁻¹) as internal standard, with subsequent stirring (3 min) and centrifugation (8 min) (triple extraction). The organic fraction was evaporated under N₂ (20 min) and the dried residue reconstituted in acetonitrile. The method was linear between 44 and 261 ng mL⁻¹, showing intra-day (2.05.6%) and inter-day (4.0–5.1%) precision with accuracy and selectiveness (curcumin t_R = 8.7 min and internal standard t_R = 13.9 min with relative recovery of 83.2%). So, it can be successfully used for curcumin evaluation in plasma samples from supplemented athletes, as well as being an alternative and advantageous method to UV–Vis and MS/MS in bioavailability studies.     

Encapsulation of drugs into large unilamellar liposomes prepared by an extemporaneous method

Abstract

The method we developed for extemporaneous preparation of large unilamellar liposomes (Philippot et al. 1984) was applied to the encapsulation of 12 different antibiotic, anti-asthmatic and anti-inflammatory drugs. The behaviour of these drugs, during encapsulation, assigns them to one of the three classes: hydrophilic, hydrophobic or both. Alone, the first type of compound gave an appreciable encapsulation. However, the entrapment yield depended on the respective charges of the liposome and the drug. The amphiphile molecules tested are permeant and thus did not stay inside the liposomes. Only one of the hydrophobic drugs analysed associated with the liposome membrane lipids with a good yield.     

Encapsulation of drugs into large unilamellar liposomes prepared by an extemporaneous method

The method we developed for extemporaneous preparation of large unilamellar liposomes (Philippot et al. 1984) was applied to the encapsulation of 12 different antibiotic, anti-asthmatic and anti-inflammatory drugs. The behaviour of these drugs, during encapsulation, assigns them to one of the three classes: hydrophilic, hydrophobic or both. Alone, the first type of compound gave an appreciable encapsulation. However, the entrapment yield depended on the respective charges of the liposome and the drug. The amphiphile molecules tested are permeant and thus did not stay inside the liposomes. Only one of the hydrophobic drugs analysed associated with the liposome membrane lipids with a good yield.